Candidates for 2016 ERP of the Year

III.

PDE5 Inhibitors– August 4, 2015

PDE5 Inhibitors ERP Members Present:

Brian Schaneberg, Starbucks (Chair); Phil Koerner, Phenomenex; Katerina Mastovska, Covance; Tom Phillips,

State of MD; Fenhong Song, FDA; John Spzylka, Mérieux NutriSciences; Darryl Sullivan, Covance.

PDE5 Inhibitors ERP Members Absent:

Teresa Cain, FDA; Liton Roy, Sancilio; Jerry Zweigenbaum, Agilent.

AOAC Method #

Manuscript Title

ERP Decisions

Consensus

Reviewers

PDE5-001

Title:

Screening Method for

Phosphodiesterase Type 5 (PDER5)

Inhibitors in Dietary Ingredients and

Supplements using High Resolution

Mass Spectrometry

Submitter:

Brian Musselman, IonSense

Motion 1:

MOTION to not move PDE5-001 to First Action

Official Methods

status.

Motion 2:

ERP finds this method intriguing and would like to

see a further submission of data demonstrating

applicability towards the SMPR 2014.012.

Motion 1:

Phillips/Sullivan,

6/0/1 (Abstain:

Covance)

Motion 2:

Phillips/Sullivan,

6/0/1 (Abstain:

Covance)

Primary:

Tom Phillips

Secondary:

Not

Submitted

PDE5-002

Title:

Screening Method for

Phosphodiesterase Type 5 (PDE5)

Inhibitors in Dietary Ingredients and

Supplements

Submitter:

Tien Do, Camag

Motion 1:

MOTION to not move PDE5-002 to First Action

Official Methods

status.

Motion 2:

MOTION that the ERP finds this method valuable for

screening and would like to see a further submission

of data demonstrating applicability towards the

SMPR 2014.012.

Motion 1:

Mastovska/Koerner,

6/0/1 (Abstain:

Covance)

Motion 2:

Mastovska/Spzylka,

6/0/1 (Abstain:

Covance)

Primary:

Katerina

Mastovska

Secondary:

Not

submitted

PDE5-003

Title:

Adaption of the LC-MS Screen for

PDE5 Inhibitors to UHPLC-MS

Submitter:

Elisa Nickum, FDA

Motion 1:

MOTION to not move PDE5-003 to First Action

Official Methods

status.

Motion 2:

MOTION that this method should:

Supply single lab validation data related to

LOD.

Supply LIB data if available, and any other

Motion 1:

Koerner/Phillips,

5/0/2 (Abstain:

Covance, Song)

Motion 2:

Koerner/Spzylka,

6/0/1 (Abstain:

Primary:

Phillip

Koerner

Secondary:

John Spzylka

ERP PROFILE SUMMARIES